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Cardiovascular Clinical Research in an Era of DRGs
– Paradise Lost?
Thomas D. Szucs University of Basel
Myths and Science
Thus science must begin with myths, and with
the criticism of myths; neither with the
collection of observations, nor with
the invention of experiments, but with critical discussion of myths, and of magical
techniques and practices.
- Conjectures and Refutations: The Growth
of Scientific Knowledge (1963) Karl Raimund Popper (1902-1994)
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DO DRG‘S IMPEDE INNOVATION?
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If only there were no such prejudice
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Impact of DRGs
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Total 81 studies 100%
Positive conclusion 31 38
Negative conclusion 25 30
Neutral conclusion 26 32
Brügger 2010
From uncontrolled dual financing to fix-dual financing
• Until now:
- Only partially attributed costs in basic coverage
- Guarantee of deficits of cantons
- Incentivisation through longer length of stay
• New: service-based, dual-fix financing:
• Services are transparent for insurer
• Every service covered and payed using a set „price“
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SwissDRG
Forum 2010: Pius Gyger
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No or any delayed acces to innovation?
New procedure
Covered by existing tariff
Not Covered by existing tariff
Service qustionable Service unquestionable
Tariff Short-Track-approach
Normal procedure
Service„in Evaluation“
Mandatory service: Tarif approved
No mandatory service, tariff not approved
We have a coverage process in place
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Establishing tariffs of new procedures
• Rules of tarif KVG applicable
• Negotiation hospital/ insurer
• Approval cantonal government
Coverage only for a limited period, until tariff structure Swiss DRG is in place
New procedures need to be tariffed outside of Swiss DRG, if they are non questionable (anerkannt)
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Fazit Innovationen
Endlich werden die Leistungen transparent. Das schafft die Vor-aussetzung, gute von schlechten Innovationen zu unterscheiden.
Die Schweiz kennt bereits einen Zugangsprozess für Leistungen. Wir müssen ihn nicht neu erfinden. 2
Krankenversicherer tarifieren unbestrittene bzw. zugelassene Leistungen. 3
Leistungsorientierung: endlich werden die Spitalpreise an die Leistung geknüpft. Neue Leistung = neue Verhandlung.
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Innovations and DRGs
• DRGs do not block innovations • Accepting innovations is a question of financing
rules and not a issue of the tariff system • Today we have a financing of services, not anay
more a reimbursement system • We have a process for access to new procedures
and services • New pocedures can always be tariffed between
contractual partners (hospital- insurer) • Insurers are interested in innovations
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HOW ARE PAYORS ADAPTING ?
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Transformig the roles of health plans
Porter & Teisberg (2006)
Old role: culture of denial New role: enable value-based competition on results
Restrict patient choice of providers and treatment
Micromanage provider processes and choices
Minimize the cost of each service or treatment
Engage in complex paperwork and administrative transactions with providers and subscribers to control costs and settle bills
Compete on minimizing premium increases
Enable informed patient and physician choice and patient management of health
Measure and reward providers based on results
Maximize the value of care over the full care cycle
Minimize the need for administrative transactions and simplify billing
Compete on subscriber health results
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! DRGs increases competitive pressure
! Quality requirements are increased
! Client counselling efforts increased
! Patients request more value from payors and providers
Important drivers
New hospital financing– Strategic options for payors
Patient Guidance
Partner- ships
Procurement
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Specialties List (SL)
Basic health insurance
Use within limitations
+
+
within SL limitations
+
-
“unlisted use”
Obligation to pay + -
-
-
off-label use
-
Licensed
Use within label
Listed
+ + +
+ - -
+
+
“out-of-limitations
use”
-
+
-
-
-
unlicensed use
-
-
-
Art. 71 a/b KVV
Use
Art 71a/b KVV
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WHAT IS THE ROLE OF ACADEMIC HEALTH CENTERS?
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Main benefits for firms to work with universities
• Access to new ideas, breakthroughs • Access to a large intellectual pool of
competencies or technologies • Leveraging the research budget with public
funding schemes • Spotting an recruiting the brightest young
talents • Expanding pre-competitive research • Access to specialized consultancy
Georges Haour & Laurent Miéville: From Science to Business (2011)
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Two Worlds
UNIVERSITY INDUSTRY
Commercialization of New and Useful
Technologies
Teaching
Research
Service
Economic Development
Profits
Product R&D
Knowledge for Knowledge’s
Sake
Academic Freedom
Open Discourse
Management of Knowledge for
Profit
Confidentiality Limited Public
Disclosure
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Ways in which firms engage with academia
contacts/discussions/ conferences/forums
Graduates work on companies
premises
Managers on boards/ Committees of universities
Firms hire graduates
Continuing education
Licensing and selling IP Spin-out
Collaborative Research, consulting
Donations, endowments
Joint laboratories
More institutional
Publications
Support of generic tool
Informal Education Contractual Generic
Georges Haour & Laurent Miéville: From Science to Business (2011)
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The 2 cultures
Academia Industry
Mission Education, discovery Driven by
intellectual curiosity
Mission Translational
research, commer-
cialisation, Profit making
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Who does it better?
Frye S et al. Nature Rev Drug Discovery 2011
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HOW CAN WE SUSTAIN THE FINANCING OF INNOVATION?
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Churchill emphasized the importance of seeing every crisis as an opportunity in disguise
.
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New funding opportunities
• Research bonds • Charities and foundations • Private research organisations
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Public-Private Collaborations across are required to
• Create new and more effective networks between pharmaceutical companies and their public partners (universities and hospitals)
• Mobilise knowledge and share previously unobtainable information
• Stimulate creativity by involving the entire biomedical R&D sector in Europe
• Achieve a critical mass required to solve the complex questions of biology
• Create innovation through partnerships • Increase dialogue with regulators and drive rapid
application of scientific findings • Help change the public perception of
pharmaceutical research in Europe.
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The Innovative Medicines Initiative (IMI): the largest PPP in life sciences R&D
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Crowdfunding
• Sidesteps the limitations of traditional investment channels
• Harnesses the collective power of thousands of small-scale donations from the general public
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Crowd funding
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What is crowdfunding
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CureLauncher
• CureLauncher is dedicated to crowdfunding early-stage clinical development as well as connecting patients and their families to the cutting edge of medical research.
• Aims to provide alternative funding for important research projects and clinical trials in the US through large numbers of small contributions, which could be used as primary funding or as bridge funding so projects can continue to develop their science while they wait for federal grants.
• Takes a small percentage of each pledge to make its profit.
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Impactree
The future?
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And what about funding research by payors?
• In principle, by law, impossible • However, there are options
– Health service research departments of insurers – Innovationsfonds – Trustee organisations of health insurers
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Negotiating wisely is the name of the game
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The Payor of the future
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Es ist nicht alles Gold was glänzt Not all what is gold sparkles Nur die Besten zählen Only the best count
»Es ist nicht alles Gold, lieber Sohn, was glänzet, und ich habe manchen Stern vorn Himmel fallen und manchen Stab, auf den man sich verließ, brechen sehen.« Matthias Claudius, An meinen Sohn Johannes, 1799
„Die besten Dinge im Leben sind nicht die, die man für Geld bekommt.“ Albert Einstein
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Unverhofft kommt oft Unexpected comes often Jenseits von Eden East of Edeb
Vieles geschieht unverhofft - und doch ergab eins das andere. - Else Pannek, (1932 - 2010), deutsche Lyrikerin
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Wer sucht der findet He who searches finds Das verflixte letzte Jahr The last year itch
Wer suchet, der findet - Anonym
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Jedem das Seine (Suum cuique) To each his own Irrungen und Wirrungen Trials and trubulations
Justinian (482-565)
Theodor Fontane (1819-1898)
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Wissen ist Macht Knowledge is power
Eine Unze Prävention entspricht einem Pfund Therapie An ounce of prevention is a pound of cure
Francis Bacon (1561–1626)
Benjamin Franklin (1706-1790)
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Summary
• Good news: DRGs are new and will allow for adaptation
• Bad news: The past has triggered much scepticism and frustration
• Ugly news: It might take longer than anticipated. So accept patience
Thanks to
• Pius Gyger • Matthias Früh • Wolfram Strüwe
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Thank you for your attention
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Questions?
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Contacts
Thomas D. Szucs, MD MBA MPH LLM Director; Professor of Medicine Institute of Pharmaceutical Medicine European Center of Pharmaceutical Medicine Klingelbergstrasse 61 CH-4056 Basel
T +41 61 265 76 50 F +41 61 261 76 55 E thomas.szucs@unibas.ch W www.ecpm.ch; www.szucs.ch
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References
Books • Georges Haour & Laurent Miéville. From Science to Business. How
firms create value by partnering with universities. Palgrave McMillan, 2011 ISBN 978-0-230-23651-6
• Gordon Binder and Philip Bashe. Science Lessons. What the Business of Biotech Taught Me About Management by Harvard Business Review Press, 2008
Papers • Blumenthal D. Academic–Industrial Relationships in the Life
Sciences. N Engl J Med 2008; 349: 2452 • Frye S et al. US academic drug discovery. Nat Rev Drug Disc 2011;
10: 409 • Munos B. Lessons from 60 years of pharmaceutical innovation. Nat
Rev Drug Disc 2009; 8: 959 • Kesselheim AS, Avorn J. University-Based Science and
Biotechnology Products Defining the Boundaries of Intellectual Property. JAMA 2005; 293 850
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• In der Schweiz existiert ein Zugangsprozess für neue Leistungen. Wir müssen Ihn also nicht neu erfinden wie es die Deutschen mussten.
• Gibt es eine neue (Pflicht-)Leistung, die über den Tarif noch nicht gedeckt ist, kann es bis zu 4 Jahre dauern, bis die Behandlung im DRG-System integriert ist (SwissDRG).
• Bis zur Vollendung von (2) müssen neue Leistungen ausserhalb von SwissDRG tarifiert werden, wenn sie als Pflichtleistung vom Versicherer anerkannt ist. Die Versicherer sind dann sogar verpflichtet sie zu tarifieren (da ja Pflichtleistung). Sie könnte aber auch über das VVG vergütet werden. Wichtig ist, dass diese Sondervergütung zeitlich befristet wird, bis sie im Fallpauschalenkatalog enthalten ist.
• Es gäbe auch die Möglichkeit einen Aufschlag auf die Baserate zu verhandeln. Wie ein Versicherer das tarifiert, ist letztlich seine Sache (und natürlich via Verhandlungen des Spitals).
• Spitäler können ein Entschädigungsbegehren an die Versicherer stellen. • Klinische Forschung war auch vor der DRG-Einführung und der neuen
Spitalfinanzierung nicht Teil der OKP-Preise. Musste also dazumal schon anderweitig finanziert werden. Daran hat sich nichts geändert.
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